Hypertension prevention app and web based tools

ABSTRACT

A computer system and method is disclosed as a support structure for patients with hypertension or prehypertension to encourage life style changes leading to dietary control, increase exercise and blood pressure control. The method includes automated messages and responses delivered in real time to encourage appropriate actions by the patient. A diary feature is provided for user input of various relevant parameters, such as foods consumed, exercise activities, body weight, blood pressure, and heart rate. The computer system and method may be implemented on a mobile computing device, such as a smart phone or wearable, a conventional personal computer, or a web service. Most functions will be provided on the mobile device, but some housekeeping and data visualization functions may be limited to the personal computer or web service implementations.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation in part of a U.S. patent applicationSer. No. 14/868,315 filed Sep. 28, 2015, which claims priority to U.S.Patent Application No. 62/055,918, filed Sep. 26, 2014, the entirecontents of which are incorporated by reference.

FIELD OF THE INVENTION

This invention pertains to the area of software for the management ofmedical conditions, in particular, for the prevention and reduction ofhigh blood pressure.

BACKGROUND OF THE INVENTION

Hypertension is the primary cause of death of approximately 348,000Americans each year. Approximately 76 million Americans, or 34% of theadult population, have hypertension and an additional 30 million haveprehypertension. Hypertension or high blood pressure makes the heartwork harder and the increased pressure can damage vessels and organs.

The risks from hypertension increase with age. Hypertension is morecommon in men, is more common in blacks and runs in families.Hypertension can result from inactivity, from using tobacco or alcohol,from too much salt, or from too little potassium or vitamin D in thediet. Hypertension can also result from stress. Hypertension is linkedto high cholesterol, diabetes, and kidney disease.

Blood pressure is measured in millimeters of mercury (mm Hg). Systolicpressure is the higher number and represents the pressure while yourheart is beating. Diastolic pressure is the lower number and representsthe pressure while your heart is filling with blood. Normal bloodpressure is 120/80 or less. High blood pressure is 140/90 or greater.Blood pressure between normal and high blood pressure (120-139)/(80-89)is termed prehypertension. People with prehypertension often becomehypertensive within four years.

Hypertension makes the heart work harder resulting in damage to vesselsand organ tissue. This increases their risk for ischemic heart disease(poor heart blood flow), stroke (damage to the brain), peripheralvascular disease (poor blood flow to the limbs), aneurysms (aballoon-like vascular structure that can burst), atherosclerosis(narrowing arteries), pulmonary embolism (blocks of vessels in thelung), cognitive impairment (brain damage) and chronic kidney disease.

Many life style changes have been identified that decrease bloodpressure. The NIH Dietary Approach to Stop Hypertension (DASH) dieteffectively reduces blood pressure by 11.4 mm Hg (systolic) and 5.5 mmHg (diastolic). A DASH diet coupled with weight management and exercisereduces blood pressure by an average of 16.1 mm Hg (systolic) and 9.9 mmHg (diastolic). Aerobic exercise alone also lowers blood pressure by 4mm Hg (systolic) compared to controls. Changing to a low-sodium dietalso reduces systolic pressure by 4.6 mm Hg. Reduced alcohol consumptionlowers systolic pressure by 3.6 mm Hg and diastolic pressure by 1.8 mmHg. Increased potassium reduces systolic blood pressure by 1.8 mm Hg anddiastolic pressure by 1.0 mm Hg.

Many electronic tools are available on the web and as products that aregeared toward weight loss, dietary control and/or exercise motivation.It is important to note that these tools, as a group, have failed. Thenumber of hypertensives has rocketed due to poor eating and underactivity to include 34% of all American adults, according to NIH data.

SUMMARY OF THE INVENTION

A data-enabled apparatus and method is provided to assist persons withpre-hypertension or hypertension make life-style choices designed toreduce high blood pressure. The apparatus may be implemented on ahandheld computer such as a smartphone or tablet, or it may beimplemented on a laptop or desktop computer, or it may be implementedthrough a website.

The apparatus and method includes a software application, hereinaftertermed a “Hypertension Prevention Module” (HPM) consisting of a computerapplication, running on computers such as Mac, Windows, iOS, Android, oras a web service. Coupled to the HPM is a “Records Management Database”(RMDB) that stores data entered by the user. The RMDB may also includepre-loaded data such as demographic and standardized medical data.

The HPM is programmed to interact with users in real time and processhistorical data entered by the user along with pre-loaded medical datato encourage proper eating, sufficient exercise, weight loss, reducedsodium consumption, increased consumption of potassium containing foods,and reduction of alcohol consumption. The apparatus and method isdesigned to be used by prehypertensive users to reduce their bloodpressure normal values.

The HPM can be used as a method that routinely interacts with users overthe course of a day. In various embodiments of the method, the followinginteractions may be employed:

-   -   Users may be asked questions that quiz their knowledge of        lifestyle choices that affect blood pressure.    -   Users may be asked questions about their food choices at meal        times.    -   Users may be asked about relevant medical data such as body        weight and blood pressure.    -   Users may be given suggestions about what and when to eat.    -   Users may be given suggestions about their exercise.

Key components of the HPM may include:

-   -   A user interface provided in a mobile app, a laptop or desktop        computer, or a website.    -   An educational component for an induction period of the first        six weeks of the program using multiple choice questions.    -   A user database having data entry and review component (also        termed herein a “diary”) that allows users to enter data such as        medical data, food choices, and exercise that also allows users        to track and review their progress.    -   A “Virtual Coach” component that displays intelligent messages        and reminders to users in real time based on their data entry.        For example, the Virtual Coach may remind the user to eat at a        certain time, to eat certain foods, to exercise, or to record        their medical data such as body weight and blood pressure. In        addition, the Virtual Coach may provide daily and weekly        summaries of the users' progress.    -   A mobile app that provides the educational, data entry, and        Virtual Coach components, and provides messages and reminders to        users in real time to instruct or encourage users to make        desired choices likely to reduce hypertension.    -   A smart phone step counter that allows exercise analysis and        automatic entry of exercise in the user diary.    -   Web based tools for use on Windows or Mac computers that allow        virtually all features provided by the smart phone but includes        additional features such as educational power points, questions        and answers, reminders, schedule change and can generate an        appropriate menu.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an overview of the parts of the HPM

FIG. 2 is an embodiment of a weekly summary shown on a smartphone.

FIG. 3 is a different embodiment of a weekly summary shown on asmartphone.

FIG. 4 is an embodiment of a daily summary shown on a smartphone.

FIG. 5 is flow chart of a user creation procedure.

FIG. 6 is flow chart of a user login procedure.

FIG. 7 is a flow chart of an embodiment of mobile app options.

FIG. 8 is a flow chart of an embodiment of web app or desktop appoptions.

FIG. 9 is a flow chart of an embodiment of Virtual Coach activities.

FIG. 10 is a flow chart of an embodiment of Virtual Coach activities atthe end of the day.

FIG. 11 is a flow chart of an alternative embodiment of Virtual Coachactivities at the end of the day.

FIG. 12 is a flow chart of an embodiment of Administrator options.

FIG. 13 is an embodiment of a weekly summary screen on a web app.

FIG. 14 is an alternative embodiment of a weekly summary screen web app,showing tabular and graphical blood pressure and heart rate data.

DETAILED DESCRIPTION Hypertension Prevention Module Overview

As used herein, the term “computer” refers to any device having amicroprocessor capable of running the software of the invention. Theterm may refer, for example, to a handheld device such as a smartphoneor tablet computer, which may be termed a “mobile computer,” or anotebook. laptop computer, or desktop computer, which collectively maybe termed a “personal computer.” In some embodiments, remote computers,of any design or configuration, may be employed. The terms “patient” and“user” are used interchangeably, unless the context indicates that adistinction is being made.

In an embodiment, the present invention provides a computer system foruse by a user with hypertension or pre-hypertension, comprising acomputer, a user interface operating on the computer, a recordsmanagement database stored in a non-volatile electronic medium andoperatively coupled to the computer, and a data management applicationrunning on the computer and coupled to the computer, and a displayscreen and keyboard for text input on the user interface; wherein therecords management database comprises data relevant to hypertension, andthe user enters relevant data into the records management database viathe user interface; wherein the data management application isprogrammed to process data in the records management database anddeliver pre-programmed messages to the user in real time; and whereinthe data in the records management database comprises data relevant tohypertension and the messages and questions instruct or assist the userin real time to make lifestyle choices intended to reduce hypertension.

The term “real time” herein means that an interaction or notification in“real time” is provided with no more than routine computer and dataprocessing delays. For example, a real time notification may be sent bytext message in response to a query by the user, for example, “whatshould I eat for lunch now?” Another example might be a response to acalendar item, for example, “its time to go to the gym,” that wouldappear at the calendar time when the user was supposed to go the gym.

In another embodiment of the present invention, a computer-implementedmethod for reducing blood pressure in a patient with hypertension orprehypertension is provided, including providing a computer applicationhaving a user interface, wherein the computer application stores data inone or more databases in computer memory, providing a records managementdatabase stored in a non-volatile electronic medium operatively coupledto the computer, providing a data management application coupled to theuser interface and running on a computer receiving patient data into oneor more of the databases, wherein the data comprises medical parametersrelevant to hypertension, querying the patient via the user interface ona routine basis regarding lifestyle factors that affect blood pressure,and receiving responses in real time from the patient that are stored inone or more of the databases, and providing automated suggestions on aroutine basis and in real time to the patient on lifestyle choices, thatif followed by the patient, are expected to reduce blood pressure in thepatient.

In another embodiment of the present invention, a computer-implementedmethod is provided which uses a computer application running on acomputer having a user interface, wherein the computer applicationstores data in one or more databases in non-volatile computer memory.The method receives patient data and stores the received data in adatabase, wherein the data comprises medical parameters from the patientrelevant to hypertension. The method queries the patient via the userinterface on a routine basis regarding lifestyle factors that affectblood pressure, and receives responses in real time from the patient,and storing the received responses in real time in a database. Themethod may further provide automated suggestions on a routine basis andin real time to the patient on lifestyle choices, that if followed bythe patient, are expected to reduce blood pressure in the patient. Thequerying and providing responses are preferably performed on a routinebasis, more preferably on a regular schedule. In preferred embodimentsthe application prompts the user on a regular schedule to enter patientdata via the user interface. In alternative embodiments the applicationreceives data automatically from sensors that are in communication withthe computer.

A strict diet coupled with weight management and exercise reduces bloodpressure by an average of 16.1 mm Hg (systolic) and 9.9 mm Hg(diastolic). The algorithm takes into consideration the user's aerobicexercise, which alone can lower blood pressure by 4 mm Hg (systolic)compared to controls; a low-sodium diet, which can reduces systolicpressure by 4.6 mm Hg, alcohol consumption, which when reduced lowerssystolic pressure by 3.6 mm Hg and diastolic pressure by 1.8 mm Hg andpotassium intake, which reduces systolic blood pressure by 1.8 mm Hg anddiastolic pressure by 1.0 mm Hg. A decrease in body weight by 1 kg canreduce systolic 1.2 mmHg and diastolic pressure by and 1.0 mmHg.

The key advance of the invention over previous efforts is an algorithm,designed and used to compute specific recommendations for diet andexercise for the management of hypertension Diet and exercise are theonly factors that only the patient can control, and these factors are adaily issue for everyone. This invention gives continual advice ofactual numbers to users, determined using the formulas in the softwareusing inputs of actual data entered by the user.

For example, a severely obese person might be advised to consume 1000calories or less of a low carb diet, and exercise by walking 15 minutestwice per day. In another example, a person of normal body weight mightbe advised to consume 2200 calories but exercise vigorously at least 30minutes per day.

A critical point regarding the examples in the preceding paragraph isthat the advice given is not simply canned, generic advice. It is basedon current medical recommendations and input from the user. This adviceis personalized, and it is generated by the software based on variousrules and relies on mathematical calculations.

In addition, the application is designed to interact with the userseveral times during the day. The user is prompted to add food consumed,exercise performed, and data like body weight. The application alsosends messages to the users such as advice relevant to diabetes andpraise for achieving goals. In this respect the present invention isdesigned to fulfill an unmet need in other computerized health care andhypertension education tools, by providing specific advice calculatedbased on patient input and delivering that advice routinely to the user.

Many calculators are used to “coach” the user. Many of the inputs forthese calculations come as a result of user response to notifications asdescribed above.

Calories required per day to maintain weight are then calculated basedon the user's inputs from on boarding are used to calculate caloriesrequired per day including user's personal data such as: age, weight,height, gender and activity level (1-4).

Responses to notifications and on boarding data are used to calculateUser's Body mass index (BMI) and the calories required per day for auser to maintain his/her body mass.

Inputs: weight (lb) and height (inches)

BMI=[weight/(height)]×703

Step counter measurements provide calculations of the calories burned.The user selects Monitor Exercise from screen. As a result, the stepcounter measures steps taken and duration of walk/jog as shown below. Atthe conclusion of the walk/jog, the app uses the steps counted andduration, to calculate distance walked and speed taking intoconsiderations the user's gender, (steps taken (cell phone stepcounter), walking time (cell phone step counter in minutes) and theassociated stride factor=0.413 for females and 0.415 for males)according to the following formulas:

Distance walked (miles)={[stride factor×height (inches)/12]×stepstaken}/5,280

Speed (mph)=[distance walked (miles)/walking time (min)]/60

Then, the algorithm calculates the calories burned in walking from theinputs of weight (lb), miles walked (computed above), as follows:

Calories burned=weight×miles walked×0.3

The outputs of this analysis displayed to the user as distance walked,exercise time, average speed and calories burned.

The value calculated for the calories burned, as determined with thestep counter is automatically stored in the user exercise diary.Alternatively, the user can simply input minutes for a particularexercise into their diary using the screen below. The calories burnedthrough exercise can then be calculated using published values ofcalories burned per minute for that exercise corrected for user weight.

Calories required per day (to maintain weight) are calculated based oninputs from on boarding are used to calculate calories required per dayincluding: age, weight, height, gender and activity level (1-4).

-   -   The correction for gender is to add 5 for males and subtract 161        for females    -   The correction for activity level is to multiply by 1 for        sedentary, multiply by 1.2 for low activity, multiply by 1.27        for active and multiply by 1.45 for very active.

Calories required per day=[9.9×weight (kg)+2.25×height (cm)+4.92×age inyears+gender correction]×activity correction

The algorithm also calculates the calories the user consumes daily basedon the user inputs of the following: number of servings of starches,vegetables, fruit, milk, meat/meat substitutes, fats and sweets intotheir diary at each meal. This is usually done by the user through theuser notification process. Alternatively, this can be done starting atthe main Options screen below and selecting Post Each Meal.

At the end of the day, the total number of calories consumed can becalculated from the total servings data as follows: Caloriesconsumed=starch servings×80+vegetable servings×25+fruit servings×60+milkservings×90+meat/meat substitute servings×75+fat servings×45+sweetservings×80.

Projected weight loss per week (from one day's data) is then calculatedfrom the calculations of the

calories required per day, calories burned, calories consumed.

Projected weight loss=7×(calories required+calories burned−caloriesconsumed)/3500

This data is displayed to the user as calories consumed, total caloriesburned and projected loss values.

After a daily summary an advice is presented in the form of notificationbased on these results. For instance the following text responses willbe made by the virtual coach after the daily summary:

Response Condition Please complete your diary! User has not completedentry of meal/exercise data Congratulations! You met your User meetsfood targets such dietary target. that calories consumed do not exceedtheir target by more than 10%. A good day! You nearly met your Userexceeded target calories dietary target. between 10 and 25%. Try toavoid sweets. They spike User consumed one or more your blood sugar.servings of sweets. Little progress on weight loss User exceeds targetcalories today. Make tomorrow a better by more than 25%. day by eatinghealthy!On a daily basis, the user inputs exercise data as describe above. Inaddition, each week the user receives notification (as described above)to input weight data. Alternatively, the user can decide to manuallyinput weight data.Using these data, two weekly summaries are provided (weight andexercise) to the user both in graphical and table format.In addition, the user is sent a notification of performance basedadvice:

Congratulations in meeting your User meets/exceeds exercise exercise andweight loss goals. (150 min per week) and weight loss (1 lb or more)goal. A fine week! You nearly met User is less than 30% short yourexercise and weight loss goals. of exercise goal and exhibits weightloss. Try to find time to exercise. User is more than 30% short of It isan important aspect of their exercise target but does weight loss andblood sugar not gain weight. control. Weight loss can be strongly Useris less than 30% short of impacted by fluid retention and their exercisetarget, and had other factors. Be patient and a majority of favorabledaily continue the good work! summaries for week but lost no weight orgained <1 lb. Please review the educational Subject meets criteria abovefor presentation paying careful attention the second or more week in arow. to serving sizes. Make next week a better week through a healthydiet and exercise. Little progress this week. Make Subject is more than60% short of next week a exercise better week their exercise target andweight is through healthy eating and unchanged or increased. exercise.

In addition, user's potassium can be calculated by using the averagecontent values of potassium in different foods consumed by the user.

The user is also prompted to input his/her blood pressure valuesregularly for an interval of time so that the initial blood pressurevalue can be determined.

Target Servings/Exercise Calculator

At entry to module use, the target food servings is derived from: thecalories required per day calculation given above, estimated exercisecalories used (based on 30 min walk) per day and a goal of 7% weightloss in 20 weeks:

Calorie deficit per day (to lose 7% body weight in 140 days)=(7%×userweight/140)×3500

Target calories to consume per day=calories required per day+estimatedexercise calories used per day−calorie deficit per day

From target calories the target serving per day is calculated (integervalues):Servings of starch per day=(target calories to consume each day−180)/180Servings of vegetables per day=servings of starches/2Servings of fruits per day=servings of starches/2.6Servings of meat/meat substitutes per day=servings of starches/1.5Servings of milk per day=2Servings of fats per day=servings of starches/2Servings of sweets per day=0These data are used to produce the number of servings in the menugenerator.

Target consumption of potassium and sodium are also calculated based onthe user's initial blood pressure values and usual diet, exercise,lifestyle and personal data.

Target range of exercise is calculated.

Based on the target calculations a target menu and an exercise plan aregenerated.

The historic data collected from the user's progress is stored and usedfor the calculation of a user specific coefficient which takes intoconsideration how the weight loss, low-sodium intake, potassium intakeand exercise actually have impacted the user's blood pressure values.

The coefficient is then used for the calculation of the target servingand exercise values.

Referring to FIG. 1, a flow chart of an embodiment of the overallapparatus is illustrated. A user interface is provided, that typicallywill include a display screen and an input method such as an attachedkeyboard, which may be physical or a virtual keyboard displayed on atouch screen. The display screen may be, for example, a window in acomputer application operating on a desktop or laptop computer, asmartphone screen, a tablet computer screen, or a web browser window.

The user interface may be controlled by a computer operatively linked toa Data Management Application (DMA), an application specially adaptedfor the instant purposes. The DMA may be a programmed application thatruns on the computer, developed, for example, in C++, Ruby on Rails®, orPython™. In an embodiment, the DMA may be running on a remote serverthat accesses the computer through the internet or some othercommunication means.

In an embodiment, a Records Management Database (RMDB) is connected tothe DMA. The RMDB is a database application designed to store dataentered by the user, and preloaded data, such as demographic andstandardized medical data, necessary for DMA activities.

Collectively, the entire apparatus comprising (in this embodiment) auser interface, computer, DMA, and RMDB, is termed the “HypertensionPrevention Module” (HPM).

In an embodiment, the DMA may communicate with other resources, such asservers connected to medical professionals, insurance companies,employers, personal trainers, and billing services. Typically, suchcommunication will be wirelessly in the case of handheld devices, orthrough the internet in the case of desktop and laptop computers runningthe HPM. Wireless connectivity (e.g. via Wi-Fi) with a router whichprovides Internet communication is also contemplated for any type ofdevice.

In an embodiment, the HPM may be implemented on several computerplatforms, and users can employ any one of the platforms or acombination thereof. For example, the HPM may be implemented on a mobileplatform, such as an iOS® or Android™ smartphone, a wearable computer(such as a smart watch or other jewelry), or a tablet computer. As usedin this disclosure, the term “mobile app” refers to such a use.

The HPM may also be implemented on a desktop or laptop-type computersuch as on computers running the Windows® or Macintosh® operatingsystems. Desktop or laptop-type computers are also referred to herein as“personal computers.” As used in this disclosure, the term “desktop app”refers to the HPM implemented on a desktop or laptop computer. The HPMmay also be implemented on a website. As used in this disclosure, theterm “website” refers to such a use.

In addition to the HPM, a user website may be provided, that willcontain most or all of the tools in the users personal HPM, and the userwill communicate with the HPM through the internet. The website may haveadditional tools not in the HPM. The website also may be configured togather data, either personally identifiable or anonymized, for examplefor data aggregation purposes.

Data stored by mobile apps, desktop apps, and/or websites may besynchronized so as to permit a patient to run the RMDB and DMA on morethan one platform. In other embodiments, the RMDB may run on a singleplatform while the DMA is run on multiple platforms.

In various embodiments, the HPM may be provided as a public service thatanyone can enroll in through a public registration system. In otherembodiments, the HPM may be provided as a closed system accessible onlyto members of a group, such as employees of a particular employer orhealth insurance members for a particular health insurance plan. Forsuch groups, the HPM may be a medical benefit. In either embodiment,administrative supervision and/or clinical supervision (clinicalcoordinator) may be provided. For example, administrators or clinicalcoordinators may supervise the participation and progress of HPMparticipants (users).

For example, a clinical coordinator may contact a user who appears tohave stopped using the system, for example, if a user hasn't entereddata in several days. This can be an important leg of a motivationalcomponent of the HPM. The clinical coordinator can provide encouragementor help users deal with personal problems preventing them from fullyparticipating in the program. Clinical coordinator may also manuallyflag unusual behavior (of the computer or users) for follow up. Clinicalcoordinators may also be notified automatically, or may manually flag,users who appear to be deteriorating on the program. For example a userwhose blood pressure or blood sugar level increases steadily may needadditional intervention beyond what the HPM can provide.

Initiation Overview

New users of the HPM may be required to go through an initialregistration step, including entering personal particulars andoptionally billing information that will be stored in the RMDB.

Some of the information that may be required as part of the registrationprocess includes:

-   -   Name and address, and other relevant identifying information,        for example medical insurance number.    -   Credit card or other payment information (optional)    -   Sex    -   Date of birth    -   Initial blood pressure    -   Initial body weight    -   Initial height    -   Attesting that their physician has approved them for moderate        stress exercise    -   Type of smart phone (or other mobile device)    -   Have a dietary target (as calculated below) of 1200 calories or        more    -   Have a PC that has internet access and printing capabilities

Some general criteria that are envisioned are that each participant hasa body mass index (BMI) over 27, that each participant be over 21, thatany participant is not currently on medication to treat high bloodpressure.

In addition, users may be required to provide the following informationto initialize the module:

-   -   Times during the day that the Virtual Coach will remind them to        eat well    -   times during the day for exercise and types of exercise or        sports    -   times during the day the user will desire reminders to measure        and record blood pressure and heart rate.

Educational Tools

At user log-on the first time, the user may be directed to review theeducational material before using other tools. The electroniceducational material is composed of several sections:

Basic information about hypertension

Behavior modification

Controlling your diet

Exercise

Weight loss

Description of the module

Using your educational tools: smart phone

Website Tools

In an embodiment, educational components may be available as separateselectable training modules on a website accessible to users of thesystem. For example, components covering Diet and Exercise, Using WebTools and Using Smart Phone Tools may be available on the website.

While all tools are provided at the website, they may not be convenientfor the user to employ in real time. To expect the user to log in to thewebsite to enter diary information or to review their progress on adaily summary may be unrealistic. By contrast, advice from the VirtualCoach will ideally be provided in real time for optimum effectiveness.To address these issues, diary entries (adding data to the RMDB) andVirtual Coach messages can also be added or received through the user'ssmart phone or mobile device. In a preferred embodiment, the mobile appis designed to minimize the time required for diary input. An additionaltool that may be provided on a mobile app is a step counter thatprovides full analysis of walking/jogging exercise including, distancetraveled, speed (in mph) and calories burned.

Operational Embodiments

In an embodiment, the HPM includes a “Virtual Coach,” which is anautomated system driven by the DMA module of the HPM that automaticallyinterprets and analyzes user activities based on rules pre-programmedinto the HPM. For example, if the user enters food items that may beinappropriate, the Virtual Coach may send a message to the userrecommending an alternative food choice. The Virtual Coach may also sendreminders at specific times of the day, such as at times when exerciseor eating is recommended. Such reminders may be via SMS text or aspop-up reminders on mobile devices. The Virtual Coach may send remindersfor users to measure the blood pressure or body weight and enter it intotheir diary.

In an embodiment, the Virtual Coach may also ask the user aboutcompliance with medications, including sending reminders to takemedication when appropriate, and/or following up to confirm that thatthe user took the correct medication. The Virtual Coach may coordinatewith a medical practitioner on this aspect, to adjust dosages or timeswhen the user is reminded to take their medication.

In other embodiments of the Virtual Coach, a multiple choice questionmay be presented to users, for example early in the morning. The VirtualCoach may send a text message at each meal and snack reminding the userto eat appropriately and enter the foods eaten and salt consumed intotheir diary. For example, a Virtual Coach text message may be: “It istime for breakfast. Remember to eat healthy! Would you like to enteryour meal into your diary? Don't forget to enter salt consumed.” Theuser may also receive a text message reminding them to exercise and torecord their exercise in their diary. The Virtual Coach may provide theparticipant with a daily summary of their progress at the end of the dayas well as a performance based notification encouraging them for thefollowing day. Finally, the user may receive reminders to measure andrecord their body weight, their blood pressure and heart rate each week.Users may receive a weekly progress summary as well as a performancebased encouragement notification for the coming week. The actual timethe notifications are delivered are selectable by the user. These timescan be modified by the user, for example, at the website.

In an embodiment, after the initiation process is completed, there is apreliminary phase to the program, in which each morning for the firstsix weeks just prior to breakfast, a multiple choice question will besent to each user. In a preferred embodiment, the question will be sentvia a mobile app, since most people are preparing for their day prior tobreakfast and likely not sitting down at a desktop computer.

These multiple choice questions may do two things: (1) they maycondition the user to think about controlling their eating and planningfor exercise that day and (2) they may help reinforce the educationalcomponents of this program.

A sample multiple choice question may be:

Question: What is the best way to prevent hypertension?

-   -   A. A diet rich in fruits and vegetables    -   B. A low salt high potassium diet    -   C. Lose weight    -   D. All of the above

When the user selects the correct answer (here, the correct answer is“D”), the Virtual Coach will confirm that it is correct. When a userselects the wrong answer, the Virtual Coach will tell the user that theanswer is wrong and provide the correct answer. The Virtual Coach willnext ask the user to enter their breakfast foods into the diary.

Users may log in to use their electronic diary with the mobileapplication at any time. After logging on, users will be presented witha main menu of options for the HPM. In an embodiment, users may haveoptions to enter dietary, exercise, weight, blood pressure or heart ratedata into the HPM. They may also choose to monitor their exercise orlook at performance summaries such as their daily or weekly summary.

Mobile App Options

Various options are presented to the user on the mobile app that can beinitiated by the user. An embodiment of a list of options is shown inFIG. 7.

In an embodiment, a “Post Each Meal” menu item on the main menu returnsa set of button for meals to choose from, for example, breakfast, lunch,midafternoon snack, etc. After selecting the appropriate meal, the userwill be able to enter foods eaten for that meal. If the user isresponding to a text reminder to eat, this step may be omitted—the usermay be taken directly to the meal input screen allowing them to enterservings for various food items. This screen lists all food groups. Theuser inserts a number to record the number of servings of each group.This is a very efficient method of recording foods consumed into adietetic diary. An additional screen may also be presented listingcommon sources of dietary salt. The user can select the number ofservings that were consumed at that particular meal. Upon submittingthis data, salt intake will be approximated and stored in the userdiary.

Another main menu item may be to enter exercise details. In anembodiment, various exercise activities may be presented, for exampleplaying golf, walking, bicycling, playing tennis, etc. The user checksthe type of exercise, enters the minutes of exercise completed andsubmits it.

In an embodiment, the HPM mobile app may include a step counter thatthat measures how many steps taken during running or jogging, when asmart phone or wearable is carried during these activities. Access tothe step counter may be provided from the exercise option on the mobileapp. The HPM mobile app may also include a timer, allowing users topress a button at the start of an activity and at the end. When the userselects stop exercise or it stops due to inactivity, a screen may appearshowing distance walked, exercise time, average speed and caloriesburned. This information can be positive feedback to the user, and isautomatically saved in the user's diary.

Other main menu items may be to enter body weight, blood pressure, andheart rate. The user may also be reminded to do these tasks at the timesthey have selected at in advance. Blood pressure and heart rate mayoptionally be acquired directly from wearable monitoring devices thatare in communication with the computer.

When the user enters their weight to start a new week, a weekly summarymay appear as shown in FIG. 2. This summary as shown compares userweight to the past week and provides a graph of weight over a severalweek period. It also provides total weight loss in pounds and as apercent of the user's initial body mass. The user target typically willbe a weight loss of at least 3% over a 3 month period. This screen mayalso display an overview of user's overall performance in regard tocontrolling blood pressure. This screen (FIG. 3) graphically comparesuser blood pressure and heart rate to those over the past weeks. In thisway improved blood pressure can be visually appreciated. This summarymay also display minutes of exercise for the week compared to the user'starget, calories consumed in exercise for the week, and average saltconsumed for the week compared to the user's target.

Another option that may be provided are daily and weekly summaries ofclinical targets, which include blood pressure and body weight, dietaryentries, and exercise entries.

Another option that may be provided on the mobile app are forincentives. In this embodiment, health care plans can provide incentivesto encourage use of the HPM. For example, users may receive gifts ordiscounts on purchases for participation in the HPM, and for meetingclinical targets, such as weight loss or blood pressure reduction, orfor meeting dietary targets to reduce fat and sodium intake, increasepotassium intake, or to log a regular program of moderate stressexercise.

If weight and/or blood pressure targets are met, the user may consent tothe release of diary data (for the Diary Compliance, Weight Compliance,Blood Pressure (BP) Compliance) to an incentive program. In addition, amedical release may be emailed to the user to take to his/her physicianto complete in order to validate weight loss and blood pressurereduction.

In addition to the user selectable menu items, the Virtual Coach mayprovide automated messages to the user at various times each day. Forexample, a text message from the Virtual Coach may be provided thatencourages the user for the coming week based on their progress. Inanother embodiment, a user may be discouraged that their exercise isn'timpacting their weight significantly. After all, 1200 calories typicallyburned for the week through exercise is only 0.3 lb lost. But exercisehas other medical benefits. For example, users can be reminded thatexercise significantly reduces blood pressure.

In various embodiments, the Virtual Coach may include notifications fora daily multiple choice question, a reminder to eat healthy at eachmeal, a reminder that it is time to exercise and a reminder that it'stime to measure blood pressure and heart rate. In addition, the user maybe asked to input diary dietary inputs, salt consumption input, exerciseinput and blood pressure/heart rate data. The Virtual Coach may send adaily summary and a performance based text of encouragement for the nextday. Finally, on a weekly basis the user may be reminded to input theirweight and after that input a weekly summary and performance basedadvice/encouragement for the next week is provided. While this mayappear to be a cumbersome quantity of messages for the user (this couldbe as many as 136 tasks/interaction per week), the efficiency of the appis intended to make these interactions palatable for the user. Themobile app has been carefully designed and requires minimum effort tocomply with requests for diary information. The tool constantly remindsand encourages but does not interfere with the users daily activities.

As described above, the Virtual Coach has many roles that arefacilitated through the mobile app. In various embodiments, the VirtualCoach reminds users to eat well, exercise properly, and record theirfoods consumed, salt consumed, exercises completed, their weight andtheir blood pressure in the users diary. When data is not entered intothe diary, the Virtual Coach may send several reminders.

The Virtual Coach may also provide daily (FIG. 4) and weekly summaries(FIGS. 2 and 3), which are also selectable items on the main menu of themobile app. The daily summary compares target food consumption withactual for the day. It also calculates the calories consumed andcompares this to the calories used (base plus burned by exercise) tocalculate the projected weekly weight loss or gain based on the dayscaloric consumption and expenditure. In addition, the sodium consumed isestimated and compared to the target value to show how well the user iscomplying with the program.

In an embodiment, the Virtual Coach may offer performance-based advicefollowing a summary that will inform the user yet also be supportive.For example, if the user generally meets their food consumption target,the Virtual Coach will congratulate them on a great day. For minorexcesses in one or two food categories or slightly exceeding the sodiumintake target, the Virtual Coach may tell the user they had a good dayand remind them to watch their food consumption relative to theirtargets. Should consumption result in a calculated weight gain, theVirtual Coach may remind the user that tomorrow is a new day and thatthey should focus on meeting their dietary targets. Whenever excessservings of fats are indicated, the Virtual Coach may remind the userthat fats can increase blood fat level and so should be avoided. Ifthirty or more minutes of exercise is completed, the Virtual Coach mayagain congratulate them for a successful day. If exercise is completedbut falls short of target, the Virtual Coach may encourage the user tohave a better day tomorrow. If no exercise has been completed, theVirtual Coach may remind the user that tomorrow is a new day and theyshould focus on meeting their exercise target.

The weekly summary compares the users weight and blood pressure to theprior week. In addition the summary provides a plot of the users weight,blood pressure and heart rate for several past weeks while in theprogram. The summary also provides the total weight loss while in thestudy in pounds (lb s) and as a percent of total initial weight. Theweekly summary also provides the total exercise minutes for the weekcompared to the target and the total calories burned through exercisefor the week. Finally, the users blood pressure will be compared todetermine if the user is still hypertensive or if blood pressure hasreturned to normal.

In an embodiment, the Virtual Coach will offer constructive performancebased advice following each weekly summary depending on how well theuser met their exercise and weight loss targets. Weight loss is asensitive target with many variables in the near term. With diet andexercise as encouraged here, the long term trend should be towards lowerbody weight. It is important not to discourage a user that has a week oftwo where the actual weight does not meet expectations. Should the userlose a pound or more and meet their exercise target, they will becongratulated by the Virtual Coach. If weight loss is minimal but theexercise target is met or almost met, the Virtual Coach will encouragethe user by telling them that sometimes weight loss is not closelycorrelated to exercise. Users that do not meet their weight loss orexercise goals will be reminded that exercise can be an important factorin reducing blood pressure and contributes to weight loss. To users thatshow no progress in weight loss over a few weeks but appear to meetdietary and exercise targets, the Virtual Coach may suggest that theuser review the educational presentation regarding serving sizes orother remedial measures.

Health care savings can provide incentives to encourage use of the HPM.The HPM supports users in a process to lose weight, reduce fat andsodium intake, increase potassium intake, and follow a regular programof moderate stress exercise. Web and mobile tools may be designed todeliver information and receive data entered by the user. The HPM mayalso provide a summary of performance and offers performance basedadvice on a regular (daily and weekly) basis. To assist in the generalgoals of the HPM, a variety of monitors can be used to track usercompliance and performance for the HPM. The monitors may include:

-   -   Did the user complete educational training?    -   What fraction of days did the user answer a multiple choice        question?    -   How frequently was the multiple choice question answered        correctly?    -   How frequently did the user input dietary information into their        diary?    -   How frequently did the user input dietary sodium information        into their diary?    -   How frequently did the user input exercise information into        their diary?    -   How frequently did the user input blood pressure information        into their diary?    -   How frequently did the user input weight information into their        diary?    -   How frequently did the user's recorded dietary information meet        target values?    -   How frequently did the user's recorded dietary sodium        information meet target values?    -   How frequently did the user's recorded exercise information meet        target values?    -   How frequently did the user's recorded blood pressure        information meet target values?    -   How frequently did the user's recorded weight meet that        calculated based on dietary and exercise information?    -   Validated weight compliance (comparison of entered weight loss        compared to weight loss obtained from the user's physician)    -   Validated blood pressure reduced to normal (user's physician        certification that user blood pressure is in the normal range)

In an embodiment, the HPM can be used with a wellness program, forexample from a health insurance provider or employer, that providesincentives to diary compliance, weight compliance, blood pressure (BP)compliance, validated weight loss and validated blood pressurereduction. From diary inputs these data can be easily tracked and madeavailable to the user. The user is always able to see their compliancewith important module monitors and track their progress.

In any such incentive program, it is envisioned that users must consentto have their personal information transmitted to the program. Thus, inan embodiment, the user may be asked to consent to the release of diarydata (for the diary compliance, weight compliance, blood pressure (BP)Compliance) to the wellness program. In addition, a medical release maybe sent to the user to take to his/her physician to complete and returnto validate weight loss and blood pressure reduction.

Web Based Tools

In addition to the mobile app (diary and Virtual Coach), in anembodiment, a website may be provided giving users access to web-basedtools through a standard internet browser. These tools may include mostof those found in the mobile app, for example, a meal diary, saltconsumption diary, exercise diary, weight diary, blood pressure/heartrate diary, daily summary and weekly summary. These tools will allowusers to enter diary data and receive reminders and messages through thewebsite as an alternative, or in addition to, the mobile app. Inaddition, the website may provide additional tools for user profileupdate, questions and answers, study reminders, user schedule update,dynamic training, generate a dietary menu, detailed account information,and a method to opt out of the study. Details of the web based tools areprovided below.

For example, questions and answers may be made available to the user tohelp them understand hypertension and the process that they arefollowing to prevent it. At a “question and answer” screen, the user maysearch a hypertension-related database of frequently asked questions. Ifa user has a question not in the database, a messaging system may beprovided allowing the user to ask a clinical coordinator the question.The clinical coordinator may optionally add such new questions, and theanswer, to the question and answer database.

Another website feature may be a reminder screen that notifies users ofmissing diary information, such as a missing meal or missing exercisedata.

Another website feature may be a “schedule update” screen, where theuser can change their meal time or exercise text reminders. This featureprovides adaptability in the system.

Another website feature may be a “Training” option, where the user canview content, for example, a Power Point-type slide presentation,optionally with audio, on topics such Diet and Exercise, Using WebTools, or Using Mobile App Tools. An example of educational materialthat might be presented in the Training option is shown in theattachment.

Another website feature may be a Diary option that allows a review andinput of meals, sodium (salt), exercise, weight blood pressure and heartrate. This tool provides a flexible option for users to add to omittedentries, review previous entries, and change previous entries. Thiswindow also provides daily food targets and historical food data.

For example, the Diary option may have a screen for the sodium (salt)diary. This screen may list many common high salt dietary items. Userscan input the number of servings of any of these items at each meal. Anestimated salt intake is calculated based on a base salt intake (800mg/day) plus the salt consumed in any of these items selected. The dailytarget may be adjusted but is typically less than 1500 mg/day.

The Diary option may also have an exercise diary screen, allowing usersto enter and edit exercise data. Exercise may be entered by the usereach day for each exercise type (for example, walking, cycling, orswimming). A summary of the user's most recently entered exercise isalso posted in a table and graph format as shown.

The Diary option may also have a screen showing body weight (FIG. 13),showing the users weight they have entered each week. An option may beprovided on this page to enter body weight, as an alternative to themobile app. Historical weight data may be given in tabular and graphicalformats as illustrated in FIG. 13. This graphic depiction of weight(ideally trending downward in most cases) is expected to make a largeimpact on users in terms of understanding progress and their weight lossgoal, and as a motivational tool. Users may modify their exercise listat the schedule update screen.

The Diary option may also have a screen showing blood pressure and heartrate data entered by users on a daily or weekly basis (FIG. 14). Anoption may be provided on this page for users to enter their bloodpressure and heart rate each week, as an alternative to using the mobileapp. Historical blood pressure and heart rate data may be displayed inthe tabular and graphical formats as shown in FIG. 14. A graphicdepiction of blood pressure (ideally trending downward in most cases)can make a large impact on the user in terms of understanding progressand their blood pressure goal, and as a motivational tool.

Various summaries of relevant data may be provided under the diary tab.For example, FIGS. 13 and 14 show summaries of body weight and bloodpressure presented in tabular and graphical formats. Options may beprovided to show various time ranges for summary data, for example, overperiods of days, weeks, or months.

A Virtual Coach option may be provided, that includes various drop downmenus that may show daily and weekly summaries of parameters andprojections provided by the HPM. For example, the daily summary may showan overview of calories consumed, calories used, projected weight loss,minutes of exercise, sodium intake and blood pressure for each day ofthe most recent week. The user may also be able to review historicaldaily summary data. Similarly, a weekly summary may be provided, showingan overview of calories consumed, calories used, projected weight loss,minutes of exercise, sodium intake and blood pressure for recent weeks.The daily and weekly summaries may include graphical display options,allowing a user to view, for example, their blood pressure over the pasteight weeks in a graphical view. This can be a powerful tool to helpusers understand their progress. This can also be a strong motivationaltool, showing that the various lifestyle choices and changes recommendedby the HPM and Virtual Coach result in desired body changes such aslower body weight and lower blood pressure.

A “Menu of the Day” option on the main webpage menu may also beprovided, giving users a suggested menu for meals and snacks for thatday. These generated meal plans may help users get started on planningto eat right and are expected to be an important leg of the overallprogram. In an embodiment, these meal menus may be created by a randomcombination of different sets of breakfast, morning snack, lunch,afternoon snack, dinner and evening snacks. Each daily menu includes thenumber of servings for each meal and is designed to meet the nutritionaltargets for that user, such as total calories, protein, sodium, etc.Many additional features can be added to the menu including creation ofshopping list and shopping carts to satisfy the foods on the menu.

Calculators

In an embodiment, a number of calculators may be provided on the websiteand in the mobile and computer applications. Inputs for thesecalculations may come from the questionnaire and the user diary. Examplecalculations may include:

Body mass index (BMI)

-   -   Inputs: weight (lb) and height (inches)

BMI=[weight/(height²)]×703

Distance walked and speed:

-   -   Inputs: gender, steps taken (cell phone step counter), walking        time (cell phone step counter in minutes)    -   Stride factor=0.413 for females and 0.415 for males

Distance walked (miles)={[stride factor×height (inches)/12]×stepstaken}/5,280

Speed (mph)=[distance walked (miles)/walking time (min)]/60

Calories burned in walking:

-   -   Inputs: weight (lb), miles walked (computed above)

Calories burned=weight×miles walked×0.3

Calories consumed:

-   -   Inputs: servings of grain, vegetables, fruit, milk, meat, nuts,        fats and sweets (from user diary)    -   Calories consumed=grain servings×80+vegetable servings×25+fruit        servings×180+milk servings×90+meat servings×55+nut        servings×125+fat servings×45+sweet servings×80.

Calories required per day:

-   -   Inputs from questionnaire: age, weight, height, gender and        activity level (1-4) correction for gender is add 5 for males        and subtract 161 for females correction for activity level is        multiply by 1 for sedentary, multiply by 1.2 for low activity,        multiply by 1.27 for active and multiply by 1.45 for very        active.

Calories required per day=[9.9×weight (kg)+2.25×height (cm)+4.92×age inyears+gender correction]×activity correction

Projected weight loss per week: (from one day's data)

-   -   Inputs from calculators: calories required per day, calories        burned, calories consumed

Projected weight loss=7×(calories required+calories burned−caloriesconsumed)/3500

User Security

Authentication or proper qualification and/or identification of usersmay be assured by a secure user login method. All data collected fromusers and transmitted over computer networks may be stored andtransmitted in encrypted formats compliant with HIPAA standards.

App Flow Charts

Various flow charts illustrating an embodiment of the operationalfeatures of the inventions are shown in FIGS. 5 to 12.

FIG. 5 is a flow chart of a user creation procedure. Users are promptedto create a log in ID and password at step 904. In this example, usersare required to enter initial blood pressure and exercise data at step906. Step 906 also sets flags if the data is sufficient forparticipation in the study. The flags are evaluated in step 908. Forexample, a severely obese patient may require additional supervision, sostep 908 would initiate contact with the users physician. If the usermeets the parameters for the program, they will be issued logincredentials and can begin using the HPM.

FIG. 6 shows a typical user login procedure. After verification successstep 1030, the user may be presented with a multiple choice questionproviding a simple thought provoking and educational component.

FIG. 7 is a flow chart of main menu options for the mobile app. FIG. 8is a log in screen for the desktop or web app, showing menu items thatmight be used in the HPM.

FIG. 9 is a flow chart of typical activities of the Virtual Coach. Inmany cases, the beginning (step 1400 b) may be initiated automaticallysuch as with an automated reminder at a certain time of day (step 1410a). Various activities that the Virtual Coach might use are shown insteps 1430, 1440, and 1450.

FIG. 10 illustrates Virtual Coach activities at the end of the day, suchas shortly before bedtime. The Virtual Coach will review expected userinputs, such as food entries (step 1612) and exercise details (step1616), and send the user a reminder (steps 1614 and 1618 respectively)if the data entry is absent or appears to be mistaken or inaccurate. Forexample, a user who enters ten servings of broccoli for dinner may bepresumed to have made an error, so the Virtual Coach may ask forconfirmation or correction.

FIG. 11 shows the Virtual Coach review of data at the end of the day,such as shortly before bedtime, and sends users appropriate messages.

FIG. 12 is a flow chart of administrator actions that may be provided insome embodiments of the HPM. These may be actions by clinicaladministrators or computer administrators. For example, user records maybe updated by the administrator (step 810) if a user is having computertrouble.

REFERENCES

-   1. Appel L J, T J Moore, E Obarzanek, et al. For the DASH    Collaborative Research Group (1997) A clinical trial of the effects    of dietary patterns on blood pressure. N Engl J Med 336:1117-24.-   2. Smith P J, J A Blumenthal, M A Babyak, L Craighead, K A    Welsh-Bohmer, J N Browndyke, T A Strauman, and A Sherwood (2010)    Effects of the dietary approaches to stop hypertension diet,    exercise, and caloric restriction on neurocognition in overweight    adults with high blood pressure. Hypertension 55:1331-8.-   3. Whelton S P, A Chin, X Xin, and J He (2002) Effect of aerobic    exercise on blood pressure: a meta-analysis of randomized,    controlled trials. Ann Intern Med 136:493-503.-   4. Whelton P K, L J Appel, M A Espeland, et al. For the TONE    Collaborative Research Group (1998) Sodium reduction and weight loss    in the treatment of hypertension in older persons: a randomized    controlled trial of nonpharmacologic interventions in the elderly    (TONE). JAMA 279:839-46.-   5. Xin X, J He, M G Frontini, L G Ogden, O I Motsamai, and P K    Whelton (2001) Effects of alcohol reduction on blood pressure: a    meta-analysis of randomized controlled trials. Hypertension    38:1112-7.-   6. Whelton P K, J He, J A Cutler, F L Brancati, L J Appel, D    Follmann, and M J Klag (1997) Effects of oral potassium on blood    pressure. Meta-analysis of randomized controlled clinical trials.    JAMA 277:1624-32.-   7. Your Guide to Lowering Your Blood Pressure With DASH    http://www.nhlbi.nih.gov/health/public/heart/hbp/dash/new_dash.pdf

1-4. (canceled)
 5. A computer-implemented method for reducing bloodpressure in a patient with hypertension or prehypertension comprising a.providing a computer application having a user interface, wherein thecomputer application stores data in one or more databases in computermemory; b. providing a records management database stored in anon-volatile electronic medium operatively coupled to the computer; c.providing a data management application coupled to the user interfaceand running on a computer; d. receiving patient data into one or more ofthe databases, wherein the data comprises medical parameters relevant tohypertension; e. querying the patient via the user interface on aroutine basis requesting input of personal data that affects bloodpressure, selected from blood pressure measurements, heart ratemeasurements, body weight measurements, body dimension measurements,dietary intake, exercise quantity, potassium intake, and salt intake,and combinations thereof, and receiving responses in real time from thepatient that are stored in one or more of the databases; f. processingthe data stored in the records management database to generate a set ofoptimized dietary or optimized exercise, or both, recommendations forthe patient; g. providing automated suggestions on a routine basis andin real time to the patient on lifestyle choices, that if followed bythe patient, are expected to reduce blood pressure in the patient; andwherein the automated suggestions provided on a routine basis aresummarized on a weekly basis.
 6. The method of claim 5, wherein thecomputer application is an application running on a mobile device, adesktop or laptop-type computer, or a website.
 7. The method of claim 5,wherein the queries via the user interface on a routine basis areprovided to the patient at least three times per day.
 8. (canceled) 9.The method of claim 5, wherein the automated suggestions provided on aroutine basis are provided at least three times per day. 10-12.(canceled)
 13. The method of claim 5, wherein a clinical supervisormonitors the progress of the patient. 14-16. (canceled) 17-18.(canceled)